SK Bioscience wins patent nullity trial against Moderna's

'mRNA core technology patent'

Nullified the only existing mRNA use patent in KOR…won final victory after two years of proceedings

"Advancements in Korean mRNA technology…global clinical trials, including the study of Japanese encephalitis vaccine"

SK Bioscience researcher conducting an experiment related to mRNA (photo by SK Bioscience)

SK Bioscience reported on April 23 that it won patent nullity against Moderna's mRNA manufacturing technology patent.

 

Moderna’s use patent is the only mRNA manufacturing technology patent registered in Korea.

 

Korea's Intellectual Property Trial and Appeal Board recently issued a decision in favor of SK Bioscience in an invalidation trial against Moderna’s patent titled 'Modified nucleosides, nucleotides, and nucleic acids and their uses.' Moderna did not file a petition to cancel that decision within the allotted time.

 

As a result, the first-instance ruling has been finallized, giving SK Bioscience’s victory.

 

Moderna’s patent has served as core technology for mRNA vaccine production.

 

In South Korea, Moderna’s use patent is the sole registered patent covering mRNA manufacturing methods.

 

SK Bioscience filed the invalidation trial against that patent in 2023.

 

The company determined that the patent is granting undue priority and excessive exclusivity, thereby hampering mRNA vaccine technology development, and brought the suit.

 

After about two years of proceedings, the Korea's Intellectual Property Trial and Appeal Board found that the patent’s appropriatness, priority claim, and inventive step were all invalid.

 

This patent will apply to SK Bioscience’s Japanese encephalitis vaccine candidate 'GBP560' and others in development.

 

With this ruling, SK Bioscience expects its global clinical trials of GBP560 to gain momentum.

 

SK Bioscience began global Phase 1/2 clinical studies of GBP560 in February.

 

These trials are evaluating immunogenicity and safety following GBP560 administration in 402 healthy adults in Australia and New Zealand.

 

The company anticipates interim results will be available next year.

 

SK Bioscience's mRNA vaccine development began in 2022 under an agreement to receive USD 40 million in initial R&D funding from CEPI (Coalition for Epidemic Preparedness Innovations).

 

Once it enters late-stage development after completing Phase 1/2 trials, CEPI will provide up to an additional USD 100 million to SK Bioscience.

 

SK Bioscience spokesperson stated, "We secured a competitive edge in global mRNA vaccine development through this patent case," and added, "While many global firms are still undergoing patent disputes with Moderna, SK Bioscience has led the way in dismantling patent barriers and advancing its proprietary technology." "By reducing patent risk for domestic mRNA developers, we expect to contribute significantly to establishing vaccine sovereignty," the spokesperson emphasized.

 

"SK Bioscience plans to establish an mRNA vaccine platform capable of addressing a broad range of diseases beyond pandemic response and to build new pipelines to achieve global competitiveness," he added.

 

According to the global market research firm Nova One Advisor, the mRNA therapeutics market is anticipated to grow at a 17% compound annual rate, reaching USD 58.9 billion (approximately KRW 84 trillion) by 2033.